Maintenance Therapy After Radiation for Kidney Cancer

This study, called ASTROs, is looking into whether adding a year of treatment with pembrolizumab (a type of immunotherapy given through a vein) after radiation therapy can help control oligometastatic renal cell carcinoma (kidney cancer that has spread to a few other places). You may be able to join if you are 18 or older, have a confirmed diagnosis of kidney cancer with a clear cell component, and are willing to have a biopsy. The main goal is to see how often side effects occur. The study aims to enroll 144 participants, but its current status is unclear.

Study design
This is a randomized study, meaning participants will be assigned by chance to receive either pembrolizumab after radiation or observation after radiation. The study plans to enroll 144 participants.
What's involved
You would need to provide written informed consent and be willing and able to undergo a biopsy of a lesion planned for radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured through study completion, which is an average of 2 years.

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NCT06004336

A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~144 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:PembrolizumabRadiation therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over through study completion; an average of 2 years.
Oligometastatic Renal Cell Carcinoma
1 sites across 1 states
Texas1
  • Chad Tang, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Inclusion

As mandated by local health authority 6. Hepatitis B positive subjects • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
Coagulation International normalized ratio (INR) OR prothrombin time (PT)
Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase);

Exclusion

Known acute or chronic human immunodeficiency virus (HIV) infection
History of primary immunodeficiency
History of allogeneic tissue/solid organ transplant
Current or prior use of immunosuppressive medication within 7 days before the first dose of study treatment, except for topical, ocular, intranasal, and inhaled corticosteroids, or systemic corticosteroids at an equivalent dose ≤10 mg of prednisone daily.
Not a woman of childbearing potential (WOCBP) as defined in Appendix OR
A WOCBP who agrees to follow the contraceptive guidance in Appendix during the treatment period and for at least 120 days (corresponding to time needed to eliminate any study treatment(s) (pembrolizumab and/or any active comparator/combination) plus 30 days (a menstruation cycle) after the last dose of study treatment.
  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 2 years.